(and dosage form)
MYCOSTATIN CREAM and MYCOSTATIN OINTMENT for topical application each contain 100 000 units nystatin per gram.
Category A 20.1.7 Antifungal antibiotics.
Nystatin is an antibiotic with antifungal activity against a wide variety of yeasts and yeast-like fungi. The antifungal activity of nystatin is at least in part dependant on its binding to a sterol moeity, primarily ergosterol, present in the membrane of sensitive fungi, which results in an increase in the permeability of the membrane and leakage of intra-cellular components.
Nystatin exhibits no appreciable activity against bacteria.
Treatment of cutaneous mycotic infections, caused by Candida albicans (monilia). Conditions such as athlete's foot (dermatophytosis), perlèche, paronychia, intertrigo, nappy rash and other cutaneous lesions can be expected to respond.
The cream is usually preferred to the ointment in moniliasis involving intertriginous areas.
Patients with a history of hypersensitivity to any component.
DOSAGE AND DIRECTIONS FOR USE
Apply liberally to affected areas twice daily until healing is complete.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Nystatin is virtually non-toxic and non-sensitising and is well tolerated by all age groups including debilitated infants, even on prolonged administration. Large oral doses have occasionally produced diarrhoea and gastro-intestinal disturbance.
Local irritation and sensitization (including rash, dermatitis, pruritis and burning) have been reported.
If local sensitisation develops, treatment should be discontinued.
Nystatin topical preparations should not be used for the treatment of systemic or ophthalmic infections.
Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment of overdosage should be symptomatic and supportive.
MYCOSTATIN CREAM: A soft, smooth, yellow to buff, perfumed vanishing cream.
MYCOSTATIN OINTMENT: A smooth, yellow to buff, semi-opaque ointment.
MYCOSTATIN CREAM: Tubes of 15 g.
MYCOSTATIN OINTMENT: Tubes of 15 g.
MYCOSTATIN OINTMENT: Store at room temperature not exceeding 25°C. Avoid excessive heat.
MYCOSTATIN CREAM: Store at room temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN.
MYCOSTATIN CREAM: G2397 (Act 101 of 1965)
MYCOSTATIN OINTMENT: G2398 (Act 101 of 1965)
NAME AND BUSINESS ADDRESS OF APPLICANT
BRISTOL-MYERS SQUIBB (PTY) LTD*
47 Van Buuren Road,
DATE OF PUBLICATION OF THIS PACKAGE INSERT
*Authorised user of the TM MYCOSTATIN
Updated on this site: July 2005
Source: Pharmaceutical Industry
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